Accelerated Super-Hypofractionated Breast Brachytherapy - ASHBY Trial
The purpose of this study is to compare any good and bad effects of giving radiation treatment for breast cancer in 3 treatments over about 2 days.
• Female
• New diagnosis of ductal carcinoma in situ (DCIS) and/or invasive breast carcinoma per histologic evaluation
• Age 45-79 at diagnosis
• Previous lumpectomy with surgical margins histologically free of invasive tumor and DCIS as determined by the pathologist.
• T stage of Tis, T1, or T2.
• T2 tumors must be ≤3 cm in maximum diameter
• If the tumor is human epidermal growth factor receptor 2 (HER2)-positive, the patient must receive HER2-directed therapy.
• For patients with invasive breast cancer, an axillary staging procedure must be performed (either sentinel node biopsy alone or axillary dissection \[with a minimum of 6 axillary nodes removed\]) and the axillary node\[s\] must be pathologically negative.
• Note: N0(i+) is not an exclusion criterion.
• Note: Patients meeting all of the following criteria are not required to undergo the axillary staging procedure:
‣ ≥70 years of age
⁃ estrogen receptor, Her2 = human epidermal growth factor receptor 2, PR = progesterone receptor negative (ER+PR+HER2-)
⁃ G1-2
⁃ Tumor ≤2 cm in size
⁃ Agrees to comply with aromatase inhibitor recommendation
• Ability to understand and the willingness to sign a written informed consent document in English